§ 43-15.1-04 — Wholesale drug distributor and pharmacy distributor licensing requirements - Penalty

North Dakota § 43-15.1-04

• Jurisdiction: North Dakota
• Title 43: Occupations and Professions
• Ch. 43-15.1: Wholesale Drug Distributors

Text

requirements - Penalty.
1. No person may act as a wholesale drug distributor or pharmacy distributor without first
obtaining an annual license to do so from the board and paying the annual fee
required by the board.
2. The board may grant a temporary license when the wholesale drug distributor or
pharmacy distributor first applies for a license to operate within this state. A temporary
license is valid until the board finds that the applicant meets the requirements for
regular licensure.
3. The licensee shall operate in a manner prescribed by law and according to the rules
adopted by the board.
4. The board may require a separate license for each facility directly or indirectly owned
or operated by the same business entity within this state, or for a parent entity with
divisions, subsidiaries, or affiliate companies within this state if operations are
conducted at more than one location and there exists joint ownership and control
among all the entities.
5. An applicant for a license and a licensee shall satisfy the board that the applicant or
licensee has and will continuously maintain:
a. Adequate storage conditions and facilities;
b. Minimum liability and other insurance as may be required under any applicable
federal or state law;
c. A viable security system that includes afterhours, central alarm, or comparable
entry detection capability; restricted premises access; comprehensive
employment applicant screening; and safeguards against all forms of employee
theft;
d. A system of records that describes all wholesale drug distributor and pharmacy
distributor activities for at least the most recent two-year period and which is
reasonably accessible in any inspection authorized by the board;
e. Principals and persons, including officers, directors, primary shareholders, and
key management executives, who must at all times demonstrate and maintain
their capability of conducting business in conformity with sound financial practices
as well as state and federal law;
f. Complete, updated information, to be provided the board as a condition for
obtaining and retaining a license, about each wholesale drug distributor to be
licensed under this chapter, including pertinent licensee corporate, if applicable,
or other ownership, principal, key personnel, and facilities information;
g. Written policies and procedures that assure reasonable wholesale drug distributor
and pharmacy distributor preparation for, protection against, and handling of any
facility security or operation problems, including problems caused by natural
disaster or government emergency; inventory inaccuracies or product shipping

and receiving; outdated product or other unauthorized product control;
appropriate disposition of returned goods; and product recalls;
h. Sufficient inspection procedures for all incoming and outgoing product shipments;
and
i. Operations in compliance with all federal legal requirements applicable to
wholesale drug distribution.
All requirements by the board under this subsection must conform to wholesale drug
distributor licensing guidelines formally adopted by the United States food and drug
administration. In case of conflict between any wholesale drug distributor licensing
requirement imposed by the board under this subsection and any wholesale drug
distributor licensing guideline of the food and drug administration, the guideline
controls.
6. An agent or employee of any licensed wholesale drug distributor or pharmacy
distributor need not seek licensure under this section and may lawfully possess
pharmaceutical drugs when acting in the usual course of business or employment.
7. A person who violates this section is guilty of a class C felony.